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Novo Nordisk, Eli Lilly face scrutiny from EU's drug regulator over GLP-1 safety

Fierce Pharma

The EMA is scrutinizing GLP-1s, raising a safety signal about the risk that drugs from Novo Nordisk, Eli Lilly and other companies could cause cancer.

Safety 301
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Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety

Fierce Pharma

Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety aliu Wed, 05/17/2023 - 12:29

FDA 259
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CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices

Fierce Pharma

CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices. Tue, 01/17/2023 - 11:49.

Safety 326
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Considerations for safety data migration methods

European Pharmaceutical Review

In this method, Individual Case Safety Reports (ICSRs) are manually entered into the target database using outputs obtained from the source database. The list of non-transferable safety case data is fairly normalised for both E2B(R2) and E2B(R3) formats.

Safety 73
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Scott Burrows, Motivational Safety Team Speaker

Scott Burrows

It is Time to Get Accountable about Safety As a motivational safety team speaker, I am familiar with the many recent studies on isolation and loneliness. If you’re currently scratching your head as to what loneliness might have to do with safety, just stay with me for a moment as we move through…

Safety 98
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Safety analysis published for C. diff biotherapeutic

European Pharmaceutical Review

Integrated safety analysis from five prospective clinical trials for the first and only single-dose, US Food and Drug Administration (FDA)-approved microbiome -based treatment to prevent recurrent Clostridioides difficile ( C. The analysis is the largest safety evaluation to date of any microbiota-based live biotherapeutic.

Safety 96
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4 Steps Needed to Improve Patient Safety On a National Level, Per PCAST

MedCity News

The President’s Council of Advisors on Science and Technology (PCAST) issued a report that laid out four recommendations to improve patient safety across the nation. Some of these included creating federal leadership positions focused on advancing patient safety and hastening research on systems of safe care.

Safety 86